Sub Banner Default Image
Home / Jobs /

CMC Compliance Lead

CMC Compliance Lead

Back to job search

CMC Compliance Lead

  • Location:

    United States of America

  • Sector:

    Regulatory Affairs - Pharma

  • Contact:

    Yuan Xie

  • Salary:


  • Job type:


  • Contact email:

  • Job ref:


  • Published:

    17 days ago

  • Duration:

    12 months

  • Startdate:


We are hiring a experienced CMC Compliance Expert to work on a fully remote basis within the US!

Key Functions include:

* Experienced in authoring of assessment reports

* Reviewing of quality documents (e.g. reformulation studies, process validations, particle size method implementation and specification etc)

* Serve as the CMC Product Lead for assigned products

* Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes

* Manage execution / authoring of CMC documentation

Ideal candidate would have:

* Marketing authorization experience

* Project Management experience

* 8-12 years of experienced in Pharmaceutical Regulatory Industry/ CMC

(Please note that candidate's quality will be reviewed on an overall basis)

Looking forward to hearing from you soon!